Accuretic
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
30-11-2020
Summary of Product characteristics
(SPC)
24-11-2020
Active ingredient:
Hydrochlorothiazide 12.5mg; Quinapril hydrochloride 21.664mg equivalent to 20 mg quinapril free base.;
Available from:
Pfizer New Zealand Limited
INN (International Name):
Hydrochlorothiazide 12.5 mg
Dosage:
12.5mg/20mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Hydrochlorothiazide 12.5mg Quinapril hydrochloride 21.664mg equivalent to 20 mg quinapril free base. Excipient: Candelilla wax Crospovidone Heavy magnesium carbonate Lactose monohydrate Magnesium stearate Opadry pink OY-S-6937 Povidone
Units in package:
Aluminium foil, blister, sample pack, 10 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Cambrex Profarmaco Milano Srl
Product summary:
Package - Contents - Shelf Life: Blister pack, Aluminium foil - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Aluminium foil - 30 tablets - 36 months from date of manufacture stored at or below 25°C
Authorization date:
2000-02-25
Patient Information leaflet
Accuretic®
1
ACCURETIC®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ACCURETIC?
Accuretic contains the active ingredients quinapril hydrochloride and
hydrochlorothiazide. Accuretic is used to lower high blood
pressure (hypertension).
For more information, see Section 1. Why am I using Accuretic? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ACCURETIC?
Do not use if you have ever had an allergic reaction to Accuretic, any
sulfonamide or sulfur medicines or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
Accuretic? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Accuretic and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ACCURETIC?
For most patients, the usual starting dose is one Accuretic 10 mg/12.5
mg tablet a day. The dose may need to be increased to one
Accuretic 20 mg/12.5 mg tablet a day, then two Accuretic 10 mg/12.5 mg
tablets a day if necessary.
More instructions can be found in Section 4. How do I use Accuretic?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ACCURETIC?
THINGS YOU
SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
Accuretic.
Make sure you drink enough water during exercise and hot weather,
especially if you sweat a lot.
Tell your doctor if you have excess vomiting and/or diarrhoea while
taking Accuretic.
Tell your doctor immediately if you feel light-headed or dizzy after
taking your first dose of
Accuretic, or when your dose is increased.
Regularly check your skin for any new or suspicious skin lesions.
THINGS YOU
SHOULD NOT DO
Read the complete document
Summary of Product characteristics
Version: pfdacret10622
Supersedes: pfdacret11020
Page 1 of 24
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ACCURETIC 10 mg/12.5 mg film coated tablet.
ACCURETIC 20 mg/12.5 mg film coated tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACCURETIC is a fixed-combination tablet that combines an
angiotensin-converting enzyme
(ACE)
inhibitor,
quinapril
hydrochloride,
and
a
diuretic,
hydrochlorothiazide
(HCTZ).
ACCURETIC is available in two tablet strengths.
ACCURETIC 10/12.5 contains 10 mg of quinapril and 12.5 mg of
hydrochlorothiazide.
ACCURETIC 20/12.5 contains 20 mg of quinapril and 12.5 mg of
hydrochlorothiazide.
Quinapril hydrochloride is a white to off-white amorphous powder that
is freely soluble in
aqueous solvents.
Hydrochlorothiazide is a white to off-white, crystalline powder that
is slightly soluble in water,
but freely soluble in sodium hydroxide solution.
EXCIPIENT(S) WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
ACCURETIC 10/12.5 tablets: Pink, oval, biconvex, film-coated tablets,
scored on both sides.
ACCURETIC 20/12.5 tablets: Pink, triangular, biconvex, film-coated
tablets, scored on one
side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ACCURETIC is indicated for the treatment of hypertension in patients
for whom combination
therapy with quinapril and a diuretic is appropriate.
Version: pfdacret10622
Supersedes: pfdacret11020
Page 2 of 24
4.2 DOSE AND METHOD OF ADMINISTRATION
_PATIENTS NOT CURRENTLY RECEIVING A DIURETIC_
For patients not currently receiving a diuretic, whether or not they
have been receiving
quinapril monotherapy, the recommended initial dosage of ACCURETIC is
one ACCURETIC
10/12.5 tablet once daily, taken with or without food. If blood
pressure is not adequately
controlled, the dose may be increased to one ACCURETIC 20/12.5 tablet
once daily and then to
two ACCURETIC 10/12.5 tablets once daily if necessary. Further dose
increases are not expected
to produce any additional reduction in blood pre
Read the complete document
